Assessment of Myocardial Viability Using Multidetector Computed Tomography

Myocardial Infarction Clinical Trial

Official title:

Non-Invasive Assessment of Myocardial Viability Using Multidetector Computed Tomography Post Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285064
• Other study ID #: ram1099_CTIL
• Status: Completed
• Phase: N/A
• First received: January 30, 2006
• Last updated: October 11, 2008
• Start date: January 2006
• Est. completion date: May 2008

Study information

• Verified date: February 2007
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

To perform a comprehensive evaluation of multidetector CT myocardial enhancement patterns in patients with an acute ST elevation MI. In particular we plan to assess the relationship between regions with early hypoperfusion and/or late hyperenhancement, and myocardial viability.

Description:

20 patients admitted to ICCU with ST elevation MI, and treated with primary angioplasty on admission, will undergo between day 2 and 7 post-MI the following exams: a) multidetector CT: regular scan plus late scan at 10 minutes, to evaluate coronary arteries, regional function and myocardial enhancement, b) echocardiography with echo-contrast to evaluate function and size of abnormally contracting region and remodeling, c) nuclear studies: rest early and late Thallium SPECT, to evaluate perfusion and viability. At 3 months a second echo will be performed to assess recovery of abnormal segments. The perfusion defects on MSCT will be compared with the other modalities and at 3 months will be used to evaluate recovery of myocardial function i.e. viability. Parameters that will be evaluated include opacity of hypoenhanced segments, ratio of normal to abnormal segments, change in opacity between early and late scans, size and transmurality of hypoenhanced segments, and their relation to regional contraction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute ST elevation myocardial infarction

• after primary angioplasty

Exclusion Criteria:

• iodine allergy

• renal failure

• old MI

• arrhythmia

• inability to perform 20 second breath-hold

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• CT

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Philips Medical Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of viability from myocardial enhancement patterns